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Joining us today is Eric Hardy, Senior Director in Biometrics at Innovaderm Research. He is an industry specialist with a background of 27 years in clinical data management and statistics. His experience spans various domains including programming, electronic data capture (EDC), quality assurance and statistics.
This episode will cover the intricacies of system integration within clinical trials, focusing on 3 main points:
- The significance of system integration
- The benefits and drawbacks
- The details surrounding specifications and testing
The Importance of System Integration
The increasing use of various platforms to gather crucial information for clinical trials has significantly raised the demands on sites. They must navigate different requirements and processes for each system. Integrating these platforms can alleviate this burden. An example of this situation would be to integrate a subject in the electronic consent (eConsent) system and then having this profile automatically integrate data into other platforms. This ensures that when accessing these other tools, the subject’s data is already partially available. By not having to re-enter basic subject information – such as subject ID, gender, age, and date of birth – errors from duplicated data entry are prevented.
Common Additional Systems Integrated with EDC
A very common system integrated with EDC is Randomization and Trial Supply Management (RTSM), there is also Electronic Clinical Outcome Assessments (eCOA), which includes Electronic Patient Reported Outcomes (ePRO) and electronic Clinical Reported Outcomes (eClinRo) and finally, the use of eConsent is also becoming increasingly common.
Pros and Cons of System Integration
Advantages of System Integration:
1. Reducing Data Entry Errors: By entering data into a single system, the risk of data entry errors during subject creation is reduced. This integration allows the information to cascade down to other systems, minimizing the need for duplicate entries. Consequently, this approach helps prevent discrepancies that can arise from repeated data entry.
2. Ensuring Data Coherence and Integrity: Important variables that could be integrated include stratification variables, such as age, gender, or primary endpoint baseline values. Once entered into Randomization and Trial Supply Management (RTSM), this information can be pushed into EDC in a read-only format to ensure it cannot be altered in the receiving system. This approach ensures data coherence and integrity.
3. Optimizing Visit Dates Management: Another example of data that can be integrated is visit dates. In studies where drug distribution occurs at each visit, RTSM becomes the primary system for data entry by the site. By integrating visit date information into the EDC, the site avoids the need to re-enter this data. This integration prevents discrepancies and other errors associated with duplicate entries.
4. Automating Visit Date Triggers: Integrating RTSM with the ePRO system can significantly reduce the manual work required by the site. Some ePRO systems still require sites to manually trigger questionnaires based on the study visit dates. Instead of relying on sites to perform this task, automatic triggers can be set up when the systems are integrated, greatly improving efficiency.
5. Preventing Subject ID Errors: Various issues have been encountered in the past that could have been prevented by integrating the systems. For example, subjects were sometimes assigned different assigned different subject IDs in different systems. While this is a simple data entry error, it can be very difficult to correct.
Disadvantages of System Integration:
1. Data Uncertainty: Data management should be the primary focus. The collaboration among vendors is important, but it can introduce uncertainties related to the data which is not desirable from a clinical trial management standpoint.
2. Data Duplication: Another disadvantage is the duplication of information. Entering the same data multiple times across different systems can lead to discrepancies due to data entry errors. This inefficiency creates additional work for data managers, who must reconcile data issues and queries, and for sites, which must respond to these queries and correct the data.
3. Managing Stratification Variables: A notable issue can arise when a stratification variable is initially collected in an ePRO system. Without integration, the site must connect to the ePRO system, identify the correct patient, read the required values, then switch to the RTSM, select the right patient, and manually enter the data. This multi-step process increases the risk of errors, particularly in stratified variables, which can significantly impact the statistical analysis of the trial.
The Crucial Role of Specifications and Testing in System Integration
While integration offers significant advantages, it requires thorough detailing for vendors to program effectively. Clear documentation and precise specifications are essential to define which variables. This clarity eliminates ambiguity for vendors during programming. Additionally, these specifications are significant for creating test cases and conducting user acceptance testing. This process ensures that all necessary tests are performed and confirms the expected data flow and integrity across all systems.
Considerations for Developing Integration Specifications
The specifications will depend on the systems and vendors used. For example, if the same provider supplies multiple systems, integration is often readily available because these systems are typically built on a single database. However, if different providers are involved, different technologies, such as application programming interface (API), a software intermediary that allow systems to communicate may be required to facilitate integration.
Another important consideration is the simultaneous development of these systems. To create complete specifications, the original systems need to be nearly finalized. Integration typically occurs later in the process, closer to production. Therefore, close collaboration with every team involved is essential to manage the process properly and prevent any delays.
Common Misconceptions
Sometimes sponsors may think that integrating systems is not worth the additional cost, but this could not be further from the truth. While there are extra fees involved, clinical trials are so important and costly that investing in integration means investing in the quality of the study data. Costs can also be reduced by working with fewer system vendors. For example, integrating EDC, RTSM, and ePRO within a single vendor is much simple than coordinating with 3 different vendors.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
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